Targeted-Release Budesonide Shows Benefit for Patients With Severe Renal Impairment

Patients with severe renal impairment can safely be treated with Nefecon, according to study findings published in Kidney International Reports. Furthermore, Nefecon, a targeted-release budesonide formulation, has a proteinuria-lowering effect in this population.

A team of researchers in China examined the efficacy and safety of Nefecon for patients with IgA nephropathy (IgAN) who had an estimated glomerular filtration rate (eGFR) of 25 to 35 mL/min/1.73 m². Eleven patients with primary IgAN were included in the retrospective study. Patients were mostly men (63.6%) with a median age of 44 years.

Before Nefecon treatment, patients had received stable renin-angiotensin-aldosterone system inhibitors for a median duration of 56.3 months. In addition, one patient had been taking nonsteroidal mineralocorticoid receptor antagonists and two had been taking sodium-glucose cotransporter-2 inhibitors.

In this study, patients were treated with Nefecon for 9 months. At baseline, the mean urine total protein (UTP) level was 2 g/d. At 3-month follow-up, the UTP level decreased to 1.7 g/d and further decreased to 1.1 g/d at 9 months.

Moreover, the mean eGFR was 30.7 mL/min/1.73 m² at baseline. After 3 months, eGFR slightly increased to 32.4 mL/min/1.73 m² but decreased to 30.2 mL/min/1.73 m² at 9 months.

The researchers also evaluated the percentage changes in UTP and eGFR from baseline to 3, 6, and 9 months. They discovered that the mean UTP decreased by 21% from baseline to 3 months and by 35% at 6 months. The most significant decrease was 45% at 9 months. Compared with the control group, the Nefecon group showed a greater reduction in UTP at 9 months (31% vs 45%, respectively).

For eGFR, there was a mean increase of 10% from baseline to 3 months, a mean increase of 2% at 6 months, and a decrease of 2% at 9 months.

Patients tolerated Nefecon well with no severe adverse events (AEs). The most common AEs observed were weight gain (63.6%), facial edema (54.5%), upper respiratory tract infection (45.5%), and insomnia (45.5%). Two women experienced menstrual disorders. However, those were managed by an adjustment in medication dosage.

The researchers said that “our results suggest that the 9 months usage of Nefecon is generally tolerated and has a clear proteinuria-lowering effect in patients with IgAN with advanced renal dysfunction (eGFR of 25–35 ml/min per 1.73 m²).”

The researchers hope to validate their findings for clinical practice with future studies that include a larger sample size and a longer follow-up period.

Source: Ouyang Y, et al. Kidney Int Rep. 2024;10(3):935-939. doi:10.1016/j.ekir.2024.12.007